BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE DRAPE

    MDR report key: 497277 · Received October 27, 2003

    Report

    Report Number
    497277
    Event Type
    Malfunction
    Date Received
    October 27, 2003
    Date of Event
    May 1, 2003
    Report Date
    June 1, 2003
    Manufacturer
    O.R. SOLUTIONS, INC.
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT THE END OF A SURGICAL CASE THERE APPEARED TO BE A STRIKE THROUGH ON THE BOTTOM OF THE SLUSH MACHINE BENEATH THE STERILE DRAPE. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATE DRAPE SLUSHWARMER PLATE DRAPE KKX O.R. SOLUTIONS, INC. ORS-331 K3209102J

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR